By Sue Rochman
Researchers at the Kaiser Permanente Northern California Division of Research have begun recruiting patients for a randomized pragmatic clinical trial that will be conducted entirely electronically and virtually. The trial, called MITIGATE, will investigate whether a drug currently used to reduce the risk of heart disease and stroke can also prevent or reduce the risk of complications from viral respiratory illnesses in older adults with heart disease.
“This trial is only possible because Kaiser Permanente is an integrated healthcare delivery system with comprehensive electronic health records,” said study co-leader Alan S. Go, MD, a research scientist at the Division of Research and regional medical director of the KPNC Clinical Trials Program based at the Division of Research. “This would be very challenging to do in a more fragmented health care system where you don’t have the exclusive relationship with members that we do.”
Alan Go, MD, research scientist, Kaiser Permanente Division of Research, regional medical director, KPNC Clinical Trials Program.
To take part, a person must be a member of Kaiser Permanente Northern California, be age 50 years or older, have a diagnosis of atherosclerotic cardiovascular disease, and have a registered email address in order to provide informed consent electronically. A participant cannot have had COVID-19, be institutionalized, or have a life-limiting illness. Atherosclerotic cardiovascular disease is caused by the buildup of fat, cholesterol, and other substances, often referred to as plaque, in the walls of the blood vessels.
A pragmatic randomized trial evaluates a drug’s effectiveness in a real-world setting. This makes the results more broadly generalizable. “Most randomized trials have many inclusion and exclusion criteria,” said study co-leader Andrew P. Ambrosy, MD, a research scientist at the Division of Research and a cardiologist in The Permanente Medical Group. “We wanted to make this study real-world and generalizable. For that reason, we have streamlined the eligibility criteria and we are focusing on the high-risk patients for whom this drug already has an indication approved by the U.S. Food and Drug Administration.”
Andrew Ambrosy, MD, research scientist, Division of Research, cardiologist, The Permanente Medical Group.
The trial’s design will also make it easier “to quickly put the drug into clinical care if it does prove to be beneficial,” added Go.
Kaiser Permanente patients who meet the study criteria will be pre-randomized into 2 groups. One group will be contacted to see if they are interested in taking part in the study; the other group will be passively monitored only through their medical records. Patients who enroll will take part in a telehealth informed consent process and have the study drug mailed to their home. A member of the research team will check in with trial participants monthly to see if they are taking their medication and address any problems or concerns.
Ultimately, the researchers will follow 1,500 patients taking the medication and 15,000 similar patients in the control group. The study drug, Vascepa® (icosapent ethyl), contains pure and stable high-dose eicosapentaenoic acid, an omega-3 fatty acid. Six months after the last patient is enrolled, the researchers will review all of the patients’ electronic health records to see whether those taking Vascepa were less likely to be diagnosed with an upper respiratory illness, or had a less severe illness if they did get sick.
Jacek Skarbinski, MD, infectious disease specialist, The Permanente Medical Group, adjunct investigator, Division of Research.
“For a trial of this size and scope, the use of electronic health records to conduct a trial from recruitment and enrollment to outcome ascertainment is truly unprecedented,” said Ambrosy.
Vascepa is approved by the FDA to reduce the risk of heart attacks or strokes in people with heart disease or diabetes. Laboratory studies suggest the drug may also potentially have antiviral activity and anti-inflammatory effects, which could help reduce the risk of getting or becoming severely ill with a respiratory illness.
“People who have atherosclerotic cardiovascular disease are at higher risk for complications if they develop a respiratory illness,” said Jacek Skarbinski, an infectious disease specialist in The Permanente Medical Group and adjunct investigator at the Division of Research. “We look forward to seeing if Vascepa reduces these complications.”
The study is funded by Amarin Corporation, the pharmaceutical company that makes Vascepa.
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About the Kaiser Permanente Division of Research
The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and society at large. It seeks to understand the determinants of illness and well-being, and to improve the quality and cost-effectiveness of health care. Currently, DOR’s 600-plus staff is working on more than 450 epidemiological and health services research projects. For more information, visit divisionofresearch.kaiserpermanente.org or follow us @KPDOR.